Industry Survey Shows Changes on eClinical Horizon
The 2017 eClinical Landscape Study: Assessing Data Management Practices, Performance, and Challenges from the Tufts Center for the Study of Drug Development, reviews the state of data management in life sciences with an in-depth look at the insights and opinions of clinical data management professionals at more than 250 companies, including sponsors and CROs. One finding is while the industry expects to leverage a greater range of patient data in clinical trials, today companies are primarily managing eCRF data in their primary EDC system. In three years, 93% of respondents aim to use ePRO and eCOA as sources, which currently comprises only 4% of the total data managed in EDC. This is the second report and is sponsored by Veeva Systems.
Read the full release here.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
